Description and Brand Names

US Brand Name

Orudis

Orudis KT

Oruvail

Descriptions

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ketoprofen can be used to treat menstrual cramps and other conditions as determined by your doctor .

This medicine is available only with your doctor's prescription .

This product is available in the following dosage forms:

Tablet, Extended Release

Capsule, Extended Release

Tablet

Capsule

Tablet, Enteric Coated

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ketoprofen in children below 18 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ketoprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ketoprofen .

Pregnancy

Information about this ketoprofen-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Amineptine

Amitriptyline

Amitriptylinoxide

Amoxapine

Anagrelide

Apixaban

Ardeparin

Argatroban

Aspirin

Beta Glucan

Bivalirudin

Certoparin

Cilostazol

Citalopram

Clomipramine

Clopidogrel

Cyclosporine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desipramine

Desirudin

Desvenlafaxine

Dibenzepin

Dipyridamole

Dothiepin

Doxepin

Duloxetine

Edoxaban

Enoxaparin

Eptifibatide

Erlotinib

Escitalopram

Feverfew

Fluoxetine

Fluvoxamine

Fondaparinux

Ginkgo

Gossypol

Heparin

Imipramine

Lepirudin

Levomilnacipran

Lofepramine

Meadowsweet

Melitracen

Methotrexate

Milnacipran

Nadroparin

Nefazodone

Nortriptyline

Opipramol

Parnaparin

Paroxetine

Pemetrexed

Pentosan Polysulfate Sodium

Pentoxifylline

Pralatrexate

Prasugrel

Protein C

Protriptyline

Reboxetine

Reviparin

Rivaroxaban

Sertraline

Sibutramine

Tacrolimus

Tianeptine

Ticlopidine

Tinzaparin

Tirofiban

Trimipramine

Venlafaxine

Vilazodone

Vortioxetine

Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alacepril

Alprenolol

Amiloride

Arotinolol

Atenolol

Azosemide

Befunolol

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Bucindolol

Bumetanide

Bupranolol

Buthiazide

Canrenoate

Captopril

Carteolol

Carvedilol

Celiprolol

Chlorothiazide

Chlorthalidone

Cilazapril

Clopamide

Cyclopenthiazide

Delapril

Dilevalol

Enalapril

Enalaprilat

Esmolol

Ethacrynic Acid

Fosinopril

Furosemide

Hydrochlorothiazide

Hydroflumethiazide

Imidapril

Indapamide

Labetalol

Landiolol

Levobunolol

Lisinopril

Lithium

Mepindolol

Methyclothiazide

Metipranolol

Metolazone

Metoprolol

Moexipril

Nadolol

Nebivolol

Nipradilol

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Piretanide

Polythiazide

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

Spironolactone

Talinolol

Temocapril

Tertatolol

Timolol

Torsemide

Trandolapril

Triamterene

Trichlormethiazide

Xipamide

Zofenopril

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia or

Asthma or

Bleeding problems or

Blood clots or

Edema (fluid retention or body swelling) or

Heart attack, history of or

Heart disease (e.g., congestive heart failure) or

High blood pressure or

Kidney disease or

Liver disease (e.g., hepatitis) or

Stomach or intestinal ulcers or bleeding or

Stroke, history of—Use with caution. This medicine may make these conditions worse .

Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition.

Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Proper Use

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

To lessen stomach upset, you may take this medicine with food, milk, or antacid unless your doctor tells you otherwise .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules):

For osteoarthritis and rheumatoid arthritis:

Adults—At first, 75 milligrams (mg) three times a day or 50 mg four times a day. Your doctor may increase your dose, if necessary, up to a total of 300 mg a day.

Children—Use and dose must be determined by your doctor .

For mild to moderate pain or menstrual cramps:

Adults—25 to 50 mg every six to eight hours as needed. Some people may need to take as much as 75 mg every six to eight hours. Doses larger than 75 mg are not likely to give better relief.

Children—Use and dose must be determined by your doctor .

For oral dosage form (extended-release capsules):

For osteoarthritis and rheumatoid arthritis:

Adults—200 mg once a day, in the morning or evening. Take the medicine at the same time every day.

Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal pain

bloody urine

decreased frequency or amount of urine

headache

increased blood pressure

increased thirst

loss of appetite

lower back or side pain

nausea

swelling of face, fingers, feet, or lower legs

troubled breathing

unusual tiredness or weakness

vomiting

weight gain

Less common

Bladder pain

cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

rash

swelling or inflammation of the mouth

Rare

Back pain

bleeding from rectum

bleeding gums

blistering, peeling, loosening of skin

blood in vomit

bloody nose

bloody, black, or tarry stools

blurred vision

body aches or pain

burning feeling in chest or stomach

burning, dry or itching eyes

change in color of eye

chest pain

chills

clay-colored stools

cold hands and feet

coma

confusion

congestion

constipation

convulsions

cough or hoarseness

coughing or spitting up blood

cracks in the skin

dark urine

decreased urination

decreased vision or other changes in vision

diarrhea

difficult or labored breathing

difficulty swallowing

dilated neck veins

discharge, excessive tearing

dryness or soreness of throat

extreme fatigue

fast, irregular, pounding, or racing heartbeat or pulse

feeling faint, dizzy, or lightheadedness

feeling of warmth or heat

fever with or without chills

flushing or redness of skin, especially on face and neck

general tiredness and weakness

heartburn

hives or welts

increased sensitivity of skin to sunlight

indigestion

itching

joint or muscle pain

light-colored stools

loss of heat from the body

muscle pain or cramps

nervousness

noisy breathing

pale or blue lips, fingernails, or skin

pale skin

pinpoint red or purple spots on skin

pounding in the ears

problems with bleeding or clotting

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

redness or other discoloration of skin

redness or soreness around fingernails or loosening of the fingernails

redness, pain, swelling of eye, eyelid, or inner lining of eyelid

runny nose

scaly skin

severe abdominal cramping

severe or continuing stomach pain

severe sunburn

shortness of breath

skin rash, encrusted, scaly and oozing

slow heartbeat

slow or irregular breathing

sores, ulcers, or white spots on lips or in mouth

stomach pain or upset

sweating

swelling of face, ankles, or hands

tender, swollen glands in neck

tenderness in stomach area

tightness in chest

trouble in swallowing

troubled breathing with exertion

unpleasant breath odor

unusual bleeding or bruising

upper right abdominal pain

voice changes

vomiting of blood

vomiting of material that looks like coffee grounds, severe and continuing

wheezing

yellow eyes or skin

Symptoms of overdose

Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

bloated

discouragement

dreams

excess air or gas in stomach or intestines

excitation

feeling sad or empty

full feeling

general feeling of discomfort or illness

irritability

lack of appetite

loss of interest or pleasure

passing gas

sleepiness

sleeplessness

trouble concentrating

trouble sleeping

unable to sleep

Less common

Continuing ringing or buzzing or other unexplained noise in ears

disturbed color perception

double vision

halos around lights

hearing loss

loss of vision

night blindness

overbright appearance of lights

tunnel vision

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Reprint Permissions

A single copy of these materials may be reprinted for noncommercial personal use only. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research.